• R&D approver for molded component drawings, component specifications, and validations.• Led design evolution teams, coordinating multiple external partners to develop next-generation product features and improvements while reducing CoGS, reducing one part’s cost by approximately 99%. • Drove implementation of and administrated a SolidWorks PDM system.• Designed, improved, and validated test and assembly fixtures, including software and electronics.• Authored design verification test methods, templates, data analysis tools, and test instructions for assembly and equipment.• Used extensive design experience and attention to detail to detect, mitigate, and prevent product failure modes.• Led root cause and tolerance loop analyses, modifying component designs for improved performance and moldability.• Reviewed applicability of ISO 11608 to projects.• Provided templates and assistance on design verification protocols.• Held drawing reviews and updated drawings for simpler mold validation and metrology.

• Developed the system-level product requirements document, design verification plan, and risk trace matrices for a wearable auto-injector and lead a successful design verification through the development phase design review.• Authored over 140 test methods, engineering technical reports, analyses, drawings, and design verification documents.• Relied on to edit reports and coach other engineers on cGDP, Caliber RM, IBM ReqPro, Instron Bluehill software, and statistical analysis using Minitab.• Designed tools and fixtures used both in R&D testing and in manufacturing.• Set up and conducted successful validations and design verification tests, interfacing with external suppliers when needed.• Undertook initiatives to increase internal testing capabilities, leading the purchase and implementation of testing and environmental conditioning equipment.• Received Emergo audior training and conducted internal quality system audits.

• Developed needle coating machinery and processes, and methods for characterizing coating performance and quality.• Evaluated synthetic tissue analogues for needle performance characterization and designed and validated test methods using GR&R studies with ISO and ASTM standards to set materials specifications.• Developed novel suture needle coatings with significant cost advantage over current products, reduced cycle and cure times, extended pot and shelf life, and improved inter-lot consistency of needle penetration performance; improving initial penetration force by up to 23% and degradation by up to 221% on current production coatings.• Implemented process controls and improvements on production equipment, often working with external suppliers.

• Developed and inspected standard and polarization maintaining multimode and single mode fiber optic components and devices; assisting in the development and streamlining of production and storage strategies. Worked with engineering on functional specifications and detailed designs. Functioned as an intermediary between engineering, manufacturing, and administration.